BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPHASIC LIFEPAK(R) 500 AUTOMATED EXTERNAL DEFIBRILLATOR

    MDR report key: 3896965 · Received June 26, 2014

    Report

    Report Number
    3015876-2014-00718
    Event Type
    Malfunction
    Date Received
    June 26, 2014
    Date of Event
    June 2, 2014
    Report Date
    June 2, 2014
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K052057
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AFTER MULTIPLE ATTEMPTS, PHYSIO-CONTROL HAS BEEN UNABLE TO REACH THE CUSTOMER REGARDING THE RESOLUTION OF THE REPORTED DEVICE FAILURE. THE DEVICE HAS NOT BEEN RETURNED TO PHYSIO-CONTROL FOR EVALUATION. THE CAUSE OF THE REPORTED FAILURE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEIR DEVICE HAD ITS SERVICE INDICATOR ILLUMINATED AND HAD LOGGED A POTENTIALLY CRITICAL EVENT CODE WHICH COULD EFFECT DEFIBRILLATION ENERGY DELIVERY. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    374175 BIPHASIC LIFEPAK(R) 500 AUTOMATED EXTERNAL DEFIBRILLATOR DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC

    Patients

    Seq Age Sex Outcome Treatment
    1